That way when they show up, they just give the minimum notice, like snap inspection, but its very thorough.
It's funny to read this comment from you a couple of months ago of how you claimed the inspection would be "very thorough" and yet now you are supporting the naysayers that are claiming after the inspection has taken place and no Form 483 was issued that it was standard stuff / no big deal ? Sound familiar ... yes I thought so - a bit like "the FDA will likely reject the BLA resubmission as there is no new data" but once it was accepted the rhetoric from the non holders changed yet again ? You can't make this stuff up
IMO the FDA wouldn't use limited resources to undertake an overseas inspection for 10 days if they weren't at least somewhat happy with the data provided by Mesoblast in the BLA resubmission but thanks for wasting your entire weekend trying to convince us otherwise
https://hotcopper.com.au/threads/an...l-highlights.7401139/page-12?post_id=67973122
Honestly, though, they passed a routine inspection of their manufacturing facility.
This is standard stuff
Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-261
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